▎药明康德内容团队编辑GSK今天宣布，美国FDA已接受其潜在"first-in-class"口服抗生素gepotidacin的新药申请（NDA），用于治疗患有单纯性尿路感染（uUTI，也称为急性膀胱炎）成年或青少年（≥12岁）女性患者，患者体重须≥4 ...

The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics ...

GSK plc GSK announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational, ...

Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials26 March 2025 assigned as action ...

The FDA granted Priority Review to gepotidacin for the treatment of female adults and adolescents with uncomplicated UTI.

GSK's gepotidacin, an oral antibiotic for uUTIs, could be the first in over 20 years. The FDA granted Priority Review with a ...

GSK plc (GSK, GSK.L) announced the FDA has accepted the New Drug Application for gepotidacin, an oral antibiotic with a mechanism of ...

(RTTNews) - GSK plc (GSK, GSK.L) announced the FDA has accepted the New Drug Application for gepotidacin, an oral antibiotic with a mechanism of action for the treatment of female adults and ...

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GSK announced on Wednesday that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for gepotidacin, a first-in-class oral antibiotic, under priority review.

Preliminary results from the EAGLE-1 trial showed that gepotidacin, a first-in-class triazaacenaphthylene antibiotic that works by inhibiting bacterial DNA replication, demonstrated non-inferiority to ...

(Alliance News) - GSK PLC on Wednesday announced that the US Food & Drug Administration has accepted its New Drug Application for gepotidacin. The London-based biopharma company said the FDA has ...